Dutasteride Capsule, Liquid Filled
Product Images NDC 59651-021

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 59651-021). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure (Dutesteride Fig1)

A line graph comparing the mean change from baseline AUA-SI scores over 24 months of treatment between Dutasteride and placebo groups. The X-axis represents months of treatment, and the Y-axis shows the mean change from baseline. Dutasteride shows a greater decrease in AUA-SI scores over time compared to placebo, indicating more improvement in symptom scores.*

FDA Label Image

Figure (Dutesteride Fig2)

A cumulative incidence graph comparing the percentage of patients over 24 months of treatment between a placebo group and a dutasteride group. The x-axis represents months of treatment from 0 to 24, and the y-axis displays the percent of patients from 0 to 6. The chart includes cumulative event counts and numbers at risk for both groups at multiple time points.*

FDA Label Image

Figure (Dutesteride Fig3)

A line graph showing the cumulative percent of patients with events over 24 months of treatment comparing Dutasteride Group and Placebo Group. The X-axis represents months of treatment (0 to 24), while the Y-axis shows the percent of patients (0 to 6%). The Placebo Group line trends higher than the Dutasteride Group throughout the study. Below the graph, tables show cumulative events and patients at risk at specific months for both groups.*

FDA Label Image

Figure (Dutesteride Fig4)

A bar graph showing mean percent change from baseline over months of treatment (1, 3, 6, 12, 24) comparing Dutasteride and Placebo. Dutasteride is represented with white bars, Placebo with black bars, showing a greater negative change for Dutasteride at each time point.*

FDA Label Image

Figure (Dutesteride Fig5)

A line graph showing mean change from baseline in mL/sec over 24 months of treatment for Dutasteride 0.5 mg capsules compared to placebo. The x-axis represents months of treatment (0 to 24), and the y-axis shows mean change from baseline (0 to 2 mL/sec). Dutasteride shows a greater increase over time than placebo.*

FDA Label Image

Figure (Dutesteride Fig6)

A line graph depicting the mean change from baseline in IPSS (International Prostate Symptom Score) over 48 months of treatment. The graph compares three treatments: Dutasteride plus tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg, with sample sizes indicated for each treatment group at multiple time points.*

FDA Label Image

Figure (Dutesteride Fig7)

A line graph depicting mean change from baseline in mL/sec over months of treatment for Dutasteride 0.5 mg, Tamsulosin 0.4 mg, and Dutasteride plus Tamsulosin. The x-axis shows treatment duration from 0 to 24 months, and the y-axis indicates mean change in mL/sec from 0 to 3. The graph includes three lines corresponding to the three treatments with patient sample sizes noted for each time point.*

FDA Label Image

Package Label-principal Display Panel (0.5 mg (30 Tablet Bottle))

Label for Dutasteride Capsules 0.5 mg from Aurobindo Pharma Limited, containing 30 liquid-filled capsules. The label includes dosage information, storage instructions, and a warning against use by women or children. Distributed by Aurobindo Pharma USA, Inc., made in India.*

FDA Label Image

Chemical Structure (Dutesteride Str)

Chemical structure of Dutasteride, showing the molecular arrangement with multiple rings and functional groups, including trifluoromethyl groups attached to a benzene ring.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.